Cleared Traditional

K050395 - IMPEDIMED - BODY COMPOSITION ANALYSIS

K050395 is an FDA 510(k) clearance for IMPEDIMED - BODY COMPOSITION ANALYSIS, manufactured by Impedimed Pty , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code MNW cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K050395 · Impedimed Pty , Ltd. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jul 2005
Decision
147d
Days
Class 2
Risk

K050395 is an FDA 510(k) clearance for the IMPEDIMED - BODY COMPOSITION ANALYSIS. Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.

Submitted by Impedimed Pty , Ltd. (Brisbane, Queensland, AU). The FDA issued a Cleared decision on July 13, 2005 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 870.2770 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Impedimed Pty , Ltd. devices

FDA 510(k) Submission Details - K050395

510(k) Number K050395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2005
Decision Date July 13, 2005
Days to Decision 147 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 131d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNW Device Classification - Class 2, Special Controls

Product Code MNW Analyzer, Body Composition
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2770
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - MNW Analyzer, Body Composition

All 65
Devices cleared under the same product code (MNW) and FDA review panel - the closest regulatory comparables to K050395.
BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20
K052646 · Biospace Corporation Limited · Dec 2005
STAYHEALTHY BODY COMPOSITION ANALYZER, MODELS BC1 AND BC2
K052522 · Stayhealthy, Inc. · Dec 2005
SLIMMANAGER, MODEL SM-X, SM-E
K051589 · Aiia Communication, Inc. · Oct 2005
HL 188 & HL 189 BODY FAT METER
K043414 · Health & Life Co., Ltd. · Feb 2005
OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400
K043060 · Omron Healthcare, Inc. · Jan 2005
INBODY, MODEL 3.0
K042528 · Biospace Corporation Limited · Jan 2005